Major Events - InnoCare Pharma (09926) granted exclusive commercialization rights of Yixineng® to Jichuan Pharmaceutical [1] - Ying Si Intelligent (03696) received a milestone payment of HKD 39 million from Menarini, with the MEN2501 project completing its first patient dosing [1] - Xiansheng Pharmaceutical (02096) received a recent milestone payment related to the overseas licensing option agreement for SIM0500 with AbbVie [1] - Innovent Biologics (02577) completed significant design integration for related products on Google's AI hardware platform and signed a compliant supply agreement [1] - Federal Pharmaceutical (03933) obtained implied approval for clinical trials of UBT251 injection for OSA indications [1] - Kanghong Pharmaceutical (00867) received clinical trial approval for the innovative drug CMS-D017 capsule for complement-mediated kidney disease indications [1] - First Capital Holdings (00697) announced the successful IPO and listing of Shimon Holdings on the Shenzhen Stock Exchange [1] Operating Performance - Country Garden (02007) achieved a contract sales amount of approximately CNY 2.21 billion attributable to shareholders by January 2026 [1] - Nissin Foods (01475) reported an operating profit of JPY 5.672 billion from its China business segment for the first three quarters, representing a year-on-year increase of 99.8% [1] - Natural Beauty (00157) issued a profit warning, expecting an annual net profit of approximately HKD 8 million to HKD 10 million, marking a turnaround from losses [1]

Core Viewpoint - Federal Pharmaceutical (03933.HK) announced that its wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., has received clinical trial approval from the National Medical Products Administration of China for its innovative drug UBT251 injection, targeting moderate to severe obstructive sleep apnea (OSA) [1] Group 1 - The drug UBT251 is classified as a Class 1 innovative drug [1] - The clinical trial approval was granted on February 2, 2026, with acceptance number CXHL2501306 [1]

Core Viewpoint - Federal Pharmaceutical's subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., has received clinical trial approval for its innovative drug UBT251 injection for the treatment of moderate to severe obstructive sleep apnea (OSA) in China, indicating a significant advancement in addressing unmet clinical needs in this area [1] Group 1 - UBT251 injection is a multi-target peptide receptor agonist that acts on GLP-1, GIP, and GCG receptors to lower blood sugar and inhibit weight gain, positioning the company favorably in the obesity treatment market [1] - The drug is expected to fill a substantial gap in the treatment of OSA, which has a high unmet clinical demand [1] - UBT251 is also undergoing Phase II clinical trials in China for indications including overweight or obesity, type 2 diabetes, metabolic-associated fatty liver disease, and chronic kidney disease [1] Group 2 - As the first chemically synthesized GLP-1/GIP/GCG tri-target receptor agonist in China, UBT251 enhances the company's position in the research and development of this class of drugs [1] - The company aims to continue its focus on new product development to strengthen its competitiveness and creativity in the biopharmaceutical industry, which is expected to generate greater returns for the company and its shareholders [1]

Core Viewpoint - Federal Pharmaceutical (03933) announced that its wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., received clinical trial approval from the National Medical Products Administration of China for its innovative drug UBT251 injection, targeting moderate to severe obstructive sleep apnea (OSA) associated with obesity [1] Group 1: Product Development - UBT251 injection is a multi-target peptide receptor agonist developed by Federal Biotech, which acts on GLP-1, GIP, and GCG receptors to lower blood sugar and inhibit weight gain [1] - The drug is expected to address significant unmet clinical needs in the OSA treatment field, particularly for weight management [1] - UBT251 injection has also initiated Phase II clinical studies in China for indications including overweight or obesity, type 2 diabetes, metabolic-associated fatty liver disease, and chronic kidney disease [1] Group 2: Market Position and Future Plans - As the first chemically synthesized GLP-1/GIP/GCG tri-target receptor agonist new drug in China, UBT251 positions the company prominently in the research field of such medications [1] - The company aims to continue its focus on new product development to enhance its competitiveness and creativity in the biopharmaceutical industry, which is expected to generate greater returns for the company and its shareholders [1]

Core Viewpoint - Federal Pharmaceutical's wholly-owned subsidiary, Federal Biotechnology (Zhuhai Hengqin) Co., Ltd., has received clinical trial approval for its innovative drug UBT251 injection for the treatment of moderate to severe obstructive sleep apnea (OSA) in China [1] Group 1: Drug Development - UBT251 injection is a multi-target peptide receptor agonist developed independently by Federal Biotechnology, which acts on GLP-1, GIP, and GCG receptors to lower blood sugar and inhibit weight gain [1] - The drug is expected to address significant unmet clinical needs in the OSA treatment field, similar to GLP-1 class weight loss medications [1] Group 2: Clinical Trials and Research - UBT251 injection is currently undergoing Phase II clinical trials in China for indications including overweight or obesity, type 2 diabetes, metabolic-associated fatty liver disease, and chronic kidney disease [1] - As the first chemically synthesized GLP-1/GIP/GCG tri-target receptor agonist new drug in China, UBT251 positions the company prominently in this research area [1] Group 3: Future Outlook - The company aims to continue its commitment to new product development, enhancing its competitiveness and creativity in the biopharmaceutical industry, which is expected to generate greater returns for the company and its shareholders [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對 其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 ( 於開曼群島成立之有限公司 ) (股份代號: 3933) UBT251 注射液 OSA 適應症獲臨床試驗默示許可 本公告乃由聯邦制藥國際控股有限公司（「本公司」）自願發出。 本公司董事會欣然公佈，於二零二六年二月二日，本公司全資附屬公司聯邦生物科技 （珠海橫琴）有限公司（「聯邦生物科技」）自主研發的 1 類創新藥 UBT251 注射液關 於合併肥胖的中重度阻塞性睡眠呼吸暫停（OSA）適應症獲得中國國家藥品監督管理 局臨床試驗默示許可，受理號為 CXHL2501306。 UBT251 注射液是联邦生物科技自主研發的多靶點多肽類受體激動劑，可通過作用於 胰高血糖素樣肽-1（GLP-1）受體、葡萄糖依賴性促胰島素多肽（GI ...

Core Viewpoint - The announcement highlights the approval of the clinical trial registration application (IND) for the innovative drug TUL108 by the FDA, marking a significant milestone for the company in the field of anti-infection treatments [1] Group 1: Drug Development - The clinical trial registration application for TUL108, a novel broad-spectrum β-lactamase inhibitor, was approved by the FDA, with IND number 178724 [1] - TUL108 is designed to treat infections caused by both Gram-negative and Gram-positive bacteria, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), lung infections, and bloodstream infections [1] - The drug shows high sensitivity against carbapenem-resistant Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, providing comprehensive coverage for clinically urgent carbapenem-resistant Gram-negative bacteria [1] Group 2: Strategic Positioning - The development of TUL108 is expected to strengthen the company's competitive position in the anti-infection sector [1] - The company aims to continue its commitment to new product development, enhancing its competitiveness and creativity within the pharmaceutical industry [1] - The anticipated success of TUL108 is projected to generate greater returns for the company and its shareholders [1]

Core Viewpoint - The approval of the IND for TUL108 by the FDA marks a significant milestone for the company, enhancing its position in the anti-infection sector and promising potential returns for shareholders [1] Group 1: Product Development - The company announced that its wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., received FDA approval for the clinical trial registration application of TUL108, a novel broad-spectrum β-lactamase inhibitor [1] - TUL108 is designed to treat infections caused by both Gram-negative and Gram-positive bacteria, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), lung infections, and bloodstream infections [1] - The drug shows high sensitivity against carbapenem-resistant Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, addressing critical clinical needs for coverage against carbapenem-resistant Gram-negative bacteria [1] Group 2: Strategic Positioning - The development of TUL108 is expected to strengthen the company's competitive advantage in the anti-infection field [1] - The company plans to continue its commitment to new product development, aiming to enhance its competitiveness and creativity within the pharmaceutical industry [1] - The anticipated success of TUL108 is projected to generate greater returns for the company and its shareholders [1]

Core Viewpoint - The announcement highlights the FDA approval of the clinical trial registration application for TUL108, a novel broad-spectrum β-lactamase inhibitor developed by the company, which is expected to enhance its competitive position in the anti-infection field [1] Group 1: Product Development - The clinical trial registration application (IND) for TUL108 was approved by the FDA, with IND number 178724, set to commence on January 28, 2026 [1] - TUL108 is designed to treat infections caused by both Gram-negative and Gram-positive bacteria, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), lung infections, and bloodstream infections [1] - The drug shows high sensitivity against carbapenem-resistant Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, providing comprehensive coverage for clinically urgent Gram-negative bacteria resistant to carbapenems [1] Group 2: Strategic Implications - The development of TUL108 is expected to strengthen the company's position in the anti-infection sector [1] - The company aims to continue its commitment to new product development, enhancing its competitiveness and creativity within the pharmaceutical industry [1] - The anticipated success of TUL108 is projected to generate greater returns for the company and its shareholders [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對 其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份 內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 注射用 TUL108 是由本公司自主設計並研發的一種新型超廣譜 β-內醯胺酶抑制劑，擬 用於治療由革蘭氏陰性菌或革蘭氏陽性菌所引起的感染，包括複雜性尿路感染（cUTI）、 複雜性腹腔感染（cIAI）及肺部感染和血流感染。TUL108 聯合美羅培南對碳青霉烯 類耐藥大腸埃希菌、肺炎克雷伯菌、銅綠假單胞菌及鮑曼不動桿菌等均具有高度敏感 性，針對臨床極待解决的對碳青霉烯耐藥的革蘭陰性菌可實現全覆蓋。 注射用 TUL108 的研發將強化本公司於抗感染領域的優勢地位。未來，本公司將繼續 致力於新產品研發，持續提升於醫藥行業的競爭力及創造力，預期將為本公司及其股 東創造更大收益。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 ( 於開曼群島成立之有限公司 ) (股份代號: 3 ...